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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Lutonix® Drug Coated Balloon - 00801741098543

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm
LUTONIX, INC.
BSCLX3575580
In Commercial Distribution

  • 00801741098543 ()

  • Balloon Length, 80mm
  • Catheter Length, 75cm
  • Balloon Diameter, 5mm
BSCLX3575580

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098536

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm
LUTONIX, INC.
BSCLX3575560
In Commercial Distribution

  • 00801741098536 ()

  • Balloon Length, 60mm
  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
BSCLX3575560

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098529

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm
LUTONIX, INC.
BSCLX35755100
In Commercial Distribution

  • 00801741098529 ()

  • Balloon Diameter, 5mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35755100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098512

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm
LUTONIX, INC.
BSCLX35754100
In Commercial Distribution

  • 00801741098512 ()

  • Balloon Diameter, 4mm
  • Catheter Length, 75cm
  • Balloon Length, 100mm
BSCLX35754100

  • Peripheral angioplasty balloon catheter, drug-coated

Lutonix® Drug Coated Balloon - 00801741098499

LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x60mm
LUTONIX, INC.
BSCLX35130660
Not in Commercial Distribution

  • 00801741098499 ()

  • Balloon Length, 60mm
  • Catheter Length, 130cm
  • Balloon Diameter, 6mm
BSCLX35130660

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135798

Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x100
LUTONIX, INC.
LX351001240V
In Commercial Distribution

  • 00801741135798 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
LX351001240V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135781

Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x100
LUTONIX, INC.
LX351001220V
In Commercial Distribution

  • 00801741135781 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 12 millimeter
  • Balloon Length, 20 millimeter
LX351001220V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135774

Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x100
LUTONIX, INC.
LX351001060V
In Commercial Distribution

  • 00801741135774 ()

  • Balloon Length, 60 millimeter
  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
LX351001060V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135767

Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x100
LUTONIX, INC.
LX351001040V
In Commercial Distribution

  • 00801741135767 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 40 millimeter
  • Catheter Length, 100 centimeter
LX351001040V

  • Peripheral angioplasty balloon catheter, drug-coated

LUTONIX ® 035 Drug Coated Balloon PTA Catheter - 00801741135750

Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x100
LUTONIX, INC.
LX351001020V
In Commercial Distribution

  • 00801741135750 ()

  • Catheter Length, 100 centimeter
  • Balloon Diameter, 10 millimeter
  • Balloon Length, 20 millimeter
LX351001020V

  • Peripheral angioplasty balloon catheter, drug-coated
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